Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Decision coaching with a patient decision aid

• Registration Number: NCT04909580
• Lead Sponsor: Margaret Lawson

Brief Summary

A pre-/post-test design. Youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. Decision coaching guided youth and their parents in completing a patient decision aid that was pre-populated with evidence on insulin delivery options. Primary outcomes were youth and parent scores on the low literary version of the Decisional Conflict Scale (DCS).

Detailed Description

A pre-/post-test design was used. Youth with type 1 diabetes and their parent(s) were referred to the intervention by their diabetes physician. Eligible participants were youth under 18 years old with T1D and their parents, who were considering a change in insulin delivery method, capable of participating in the decision making process, and able to read and speak English or French. No lower age limit was set for youth participants, provided the youth and parent(s) could participate in the consent or assent process. Family dyads (youth and one parent) and family triads (youth and two parents) were included.

The intervention was decision coaching guided by the Ottawa Decision Support Framework for youth with type 1 diabetes and their parents using a patient decision aid that was pre-populated with evidence on insulin delivery options.

Study Timeline

• Study Start: 2013-09-05
• Primary Completion: 2015-08-31
• Study Completion: 2015-12-05
• Study First Submitted: 2019-05-07
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-28
• Last Update Submitted: 2021-05-28
• Study First Posted: 2021-06-01
• Last Update Posted: 2021-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Youth with type 1 diabetes and their parents
• considering a change in their insulin delivery method
• capable of participating in the decision making process
• able to read and speak English or French

Exclusion Criteria

• Using an insulin pump

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
decision coaching	Decision coaching with a patient decision aid	Decision coaching with a patient decision aid guided by the Ottawa Decision Support Framework

Primary Outcome Measures

Name	Time	Method
Decisional Conflict	Change from baseline decision conflict scale 14 days after intervention	Decision Conflict Scale - minimum score 0; maximum score 100

Secondary Outcome Measures

Name	Time	Method
Preferred choice	Immediately after intervention	Questionnaire asking participants for their preferred choice for insulin delivery method
Choice predisposition	Change from baseline predisposition scale to 14 days after intervention	Choice Predisposition Scale - minimum score 0; maximum score 4
Genetic Counselling Satisfaction Scale (modified version)	14 days after the intervention	Questionnaire that combined a shared decision making satisfaction rating tool and a modified version of the Genetic Counselling Satisfaction Scale

Trial Locations

Locations (1)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada